MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-11-19 for HEMOCHRON SIGNATURE ELITE INTERNATIONAL ELITE-INT manufactured by Accriva Diagnosics.
[129336607]
This mdr references accriva diagnostics' complaint number (b)(4) for the hemochron signature elite international instrument, serial number (b)(4). Accriva diagnostics' complaint numbers (b)(4) capture child complaints against two elite international instruments, serial numbers (b)(4), respectively. Accriva diagnostics' complaint numbers (b)(4) capture the two hemochron act+ reagent cuvettes, lot numbers g8jac307 and g8jac333, respectively, that were used during the procedure. This mdr serves as the initial report of the device malfunction. Once an evaluation of the instruments and reagent is completed, follow-"ip" mdr #1 will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[129336608]
Distributor in (b)(6) reported that a customer reported inconsistent act results from three hemochron signature elite international and act+ microcoagulation systems when the meters were run side-to-side during a mitral valve surgery. The patient was receiving intermittent doses of intravenous heparin with a target act of 400 seconds. Two different lots of hemochron jr act+ cuvettes were used with the meters during the procedure. Act was run using the same blood sample on the three instruments and results were discordant, but one or more values reached the therapeutic act target and were used for patient management. All three elite international instruments passed electronic qc prior to surgery. The procedure was completed successfully and no complications or other medical issues were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00027 |
| MDR Report Key | 8087607 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-11-19 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-10-24 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2018-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JON MCDERMED |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582632490 |
| Manufacturer G1 | ACCRIVA DIAGNOSTICS |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON SIGNATURE ELITE INTERNATIONAL |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2018-11-19 |
| Model Number | ELITE-INT |
| Catalog Number | ELITE-INT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCRIVA DIAGNOSICS |
| Manufacturer Address | 6260 SEQUENCE DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-19 |